TASK ORDER MEDPACE Task Order Number: 23 MEDPACE Project Number: ETA305
Exhibit 10.1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
MEDPACE Task Order Number: 23
MEDPACE Project Number: ETA305
This Task Order, dated November 12, 2014 , is between Medpace, Inc. (“Medpace”), and Coherus BioSciences, Inc. (“Sponsor”).
RECITALS:
WHEREAS, Medpace and Sponsor have entered into that certain Master Services Agreement dated January 23, 2012 (the “Master Services Agreement”); and
WHEREAS, pursuant to the Master Services Agreement, Medpace has agreed to perform certain Services in accordance with Task Orders from time to time entered into by the Parties and Sponsor and Medpace now desire to enter into such a Task Order;
WHEREAS, Medpace and Sponsor entered into a Limited Scope Agreement dated 9 February 2015 (“Limited Scope Agreement”), which amended and replaced the original Limited Scope Agreement dated 12 November 2014 wherein Medpace provided a limited set of activities related to the start up with respect to a Phase 3, An Open-label, Safety Extension Study evaluating the Long-term Safety and Response of CHS-0214 (CHS-0214-05) (the “Study”) for the study of the product CHS-0214 (“Study Product”); and
WHEREAS, now Medpace and Sponsor desire to enter into a Task Order whereby Medpace provide certain services as described herein with respect to the Study;
NOW, THEREFORE, in consideration of the mutual covenants contained herein, the Parties hereby agree as follows:
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1. |
Scope of Work: Medpace shall perform the services set forth in the Scope of Work, attached hereto as Appendix A, in accordance with the Timeline, attached hereto as Appendix B and any other documents attached to and specifically referenced in this Task Order (“Services”). |
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2. |
Compensation: For performance of these Services, Sponsor shall pay to Medpace an amount equal to the Services and Budget set forth in Appendix C, attached hereto and incorporated herein, which amount shall be payable pursuant to the Payment Schedule set forth in Appendix D, attached hereto and incorporated herein. It is agreed that [***]. Any [***] shall be [***] attached hereto as Appendix G and incorporated herein. The assumptions underlying the Services and Budget are set forth in Appendix A which is attached hereto and incorporated herein. After staff is assigned, costs are incurred based upon allocation of staff capacity. Any invoices under this Task Order may be sent to the appropriate Sponsor contact at [***]. |
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3. |
Transfer of Obligations: Sponsor Obligations transferred to Medpace by Sponsor (consistent with the regulations set forth in 21 C.F.R. Section 312, Subpart D) are identified in Appendix E. |
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4. |
MSA. The provisions of the Master Services Agreement are hereby expressly incorporated by reference into and made a part of this Task Order. |
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 1 of 44
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5. |
[***]. All Medpace Services will be charged using the [***] set forth in Appendix I attached hereto. |
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6. |
The MRL Services and Budget included in the Medpace Services and Budget is set forth in Appendix F attached hereto and incorporated herein. |
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7. |
The [***] included in the Medpace Services and Budget is set forth in Appendix G attached hereto and incorporated herein. |
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8. |
The Investigator Payment Detail included in the Medpace Services and Budget is set forth in Appendix H attached hereto and incorporated herein. |
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9. |
Limited Scope Agreement. The parties agree that the Limited Scope Agreement is superseded by this Task Order. |
IN WITNESS WHEREOF, the Parties have hereunto signed this Task Order effective as of the day and year first written above.
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MEDPACE, INC. |
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Signature: |
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/s/ Xxxx Xxxxx |
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By: |
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Xxxx Xxxxx |
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(Print Name) |
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Title: |
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Vice President |
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Commercial Operations |
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Date: |
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June 9, 2015 |
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Signature: |
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/s/ Xxxxxx Xxxxxxx |
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By: |
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Xxxxxx Xxxxxxx |
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(Print Name) |
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Title: |
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CEO |
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Date: |
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5 June, 2015 |
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 2 of 44
Appendix A: Scope of Work
Appendix B: Timeline
Appendix C: Services and Budget
Appendix D: Payment Schedule
Appendix E: Transfer of Obligations
Appendix F: MRL Services and Budget
Appendix G: [***]
Appendix H: Investigator Payment Estimate Detail
Appendix I: [***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 3 of 44
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 4 of 44
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 5 of 44
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 6 of 44
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Randomization and Supply Management
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 7 of 44
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Statistical Analysis
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 8 of 44
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 9 of 44
APPENDIX B: TIMELINE
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TASK |
DATE |
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 10 of 44
APPENDIX C: SERVICES AND BUDGET
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 11 of 44
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Fee |
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Total Service Fees |
[***] |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 12 of 44
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Prefunded & Pass-Through Expenses |
Fee |
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Total Prefunded & Pass-Through Expenses |
[***] |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 13 of 44
[***]
[***] of this Task Order [***] of the total Pre-funded Expenses are due. [***]. Sponsor shall pay such invoice [***]. [***] received from Sponsor, [***]. Medpace shall apply the [***] Pre-funded amount paid [***] against the [***], and [***].
Pass-through Costs will be billed to Sponsor [***]. Sponsor shall pay such invoice within [***] of receipt.
Pass-through Costs and Pre-funded Expenses
Any sums quoted with respect to Pass-through Costs and Pre-funded Expenses [***]. While Medpace will [***]. Payments made to third parties are [***].
Pass-through Costs may include, but are not limited to, [***]. Costs associated with, [***] are as detailed in the table below.
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Cost* |
Description |
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[***] |
[***] |
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
|
* |
Currency is [***]. Costs are subject to change based on [***]. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 14 of 44
Medpace will pass-through [***]. This will include [***].
|
Item |
Cost |
Description |
|
[***] |
[***] |
[***] |
|
[***] |
[***] |
|
|
* |
Currency is [***] |
Pre-funded Expenses
Pre-funded Expenses may include, but are not limited to, [***]. Investigator fees are [***]. The investigator fee amount [***]. The laboratory fee amount [***]. With the exception of [***], Medpace will seek the prior written approval of the budget by Sponsor before signing an agreement (including amendments) with Pre-funded Vendors.
Additional Costs
[***]
All Direct Fees are [***]. All such changes [***]
[***]. After staff are assigned, [***].
Inflation
[***]
Currency and Exchange Rate
The currency of this Task Order is United States Dollars unless otherwise provided herein.
Medpace will invoice Sponsor for Pass-through Costs and Pre-funded Expenses incurred and/or [***]. The Direct Fees detailed in this Task Order were calculated using [***]. [***].
[***]
Applicable Taxes
All Direct Fees, Pass-through Costs, and Pre-funded Expenses are quoted excluding any [***], which include but are not limited to [***], which may be payable to Medpace by Sponsor.
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 15 of 44
APPENDIX E: TRANSFER OF OBLIGATIONS
CONFIDENTIAL
Directions: Complete the form below for Sponsor obligations that have been transferred in accordance with 21 CFR Part 312, Subpart D (Responsibilities of Sponsors). Forward the completed form to Sponsor’s Regulatory Affairs Department for submission to the applicable regulatory agencies.
|
Drug: |
CHS-0214 |
Study ID: |
CHS-0214-05 |
|
Study Title: |
An Open-label, Safety Extension Study evaluating the Long-term Safety and Response of CHS-0214 (CHS-0214-05) |
||
|
CRO Name: |
Medpace |
||
|
CRO Address: |
0000 Xxxxxxx Xxx, Xxxxxxxxxx, Xxxx 00000 |
||
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 16 of 44
APPENDIX F: MRL Services and Budget
See attached budget on next page.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 17 of 44
|
Sponsor: |
Coherus BioSciences |
[***] |
|
Protocol: |
CHS-0214-05 |
|
|
[***] |
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
|
|
|
|
Total Medpace Reference Laboratories Fees |
[***] |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 18 of 44
|
Medpace Reference Laboratories Fee Estimate [***] |
|||||||||||
|
Sponsor Coherus BioSciences |
|
|
|
|
|
|
|
|
|
|
|
|
Protocol: CHS-0214-05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
|
|
|
||||||
|
|
Unit Cost |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
Total Number of Units |
Cost |
Subtotal |
|
Laboratory Tests |
|
|
|
|
|
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
|
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laboratory Support Services |
|
|
|
|
|
|
|
|
|
|
[***] |
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Medpace Reference Laboratory Fees |
|
|
|
|
|
|
|
|
|
|
[***] |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 19 of 44
|
Medpace Reference Laboratories Fee Estimate [***] |
|||||||||||
|
Sponsor Coherus BioSciences |
|
|
|
|
|
|
|
|
|
|
|
|
Protocol: CHS-0214-05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
|
|
|
||||||
|
|
Unit Cost |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
Total Number of Units |
Cost |
Subtotal |
|
Laboratory Tests |
|
|
|
|
|
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laboratory Support Services |
|
|
|
|
|
|
|
|
|
|
[***] |
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Medpace Reference Laboratory Fees |
|
|
|
|
|
|
|
|
|
|
[***] |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 20 of 44
|
Medpace Reference Laboratories Fee Estimate [***] |
|||||||||||
|
Sponsor Coherus BioSciences |
|
|
|
|
|
|
|
|
|
|
|
|
Protocol: CHS-0214-05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
|
|
|
||||||
|
|
Unit Cost |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
Total Number of Units |
Cost |
Subtotal |
|
Laboratory Tests |
|
|
|
|
|
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laboratory Support Services] |
|
|
|
|
|
|
|
|
|
|
[***] |
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
|
|
[***] |
[***] |
|
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Medpace Reference Laboratory Fees |
|
|
|
|
|
|
|
|
|
|
[***] |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 21 of 44
|
Medpace Reference Laboratories Pass Through Fee Estimate
|
||||
|
Sponsor Coherus BioSciences |
||||
|
Protocol: CHS-0214-05 |
||||
|
|
Average Cost |
Estimated |
Total Cost |
Subtotal |
|
Pass Through Estimates |
|
|
|
[***] |
|
[***] |
|
|
|
|
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Medpace Reference Laboratory Fees |
|
|
|
[***] |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 22 of 44
Transportation Rates
|
Country |
Sites |
Number Randomized |
Number Ambient / Refrigerate Shipments |
Number Frozen Shipments |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
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[***]
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 23 of 44
|
Transportation Rates |
[***] |
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Country |
Sites |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 24 of 44
APPENDIX G: [***]
See attached budget on next page.
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 25 of 44
TASK ORDER #6
SUBCONTRACTOR Task Order Number: 6
SUBCONTRACTOR Project Number: CHS-0214-05
This Task Order, dated October 27th, 2014, is between Medpace, Inc. (“PRIME“), and [***] (“Subcontractor“).
RECITALS:
WHEREAS, PRIME and Subcontractor have entered into that certain Master Subcontract Agreement dated 1 October 2012 (the “Master Subcontract Agreement”); and
WHEREAS, pursuant to the Master Subcontract Agreement, Subcontractor has agreed to perform certain Services in accordance with Task Orders from time to time entered into by the Parties and PRIME and Subcontractor now desire to enter into such a Task Order; and
WHEREAS, Subcontractor may subcontract the portion of clinical study activities to [***], an affiliate of Subcontractor (“[***]”); and
WHEREAS, Subcontractor and PRIME desire that Subcontractor provide certain services with respect to a Double-Blind, Randomized, Parallel-Group, Active-Control Study to compare the Efficacy and Safety of CHS-0214 Versus Enbrel® in Subjects with Rheumatoid Arthritis and Inadequate Response to Treatment with Methotrexate (the “Study”) for the study of the product CHS-0214 (“Study Product”) as set out in the Protocol Number: CHS-0214-05, which is incorporated herein by reference, sponsored by Coherus Biosciences, Inc. (the “Sponsor”);
NOW, THEREFORE, in consideration of the mutual covenants contained herein, the Parties hereby agree as follows:
|
1. |
Scope of Work. PRIME agrees that [***] shall perform the services described in the Scope of Work, attached hereto as Appendix 1, in accordance with the Project Schedule, attached hereto as Appendix 2 and any other documents attached to and specifically referenced in this Task Order (“Services”). PRIME acknowledges [***] will perform the Services on behalf of Subcontractor. PRIME may communicate with [***] directly and accepts [***]'s direct communication to PRIME relating to the Services. |
|
2. |
Performance Standards. [***] performs the Services pursuant to Master Subcontract Agreement and this Task Order in compliance with the Applicable Law, GCP, PRIME's standard operating procedures (“SOP”) and other protocol provided prospectively to Subcontractor for review. The Parties including [***] may amend the SOP if [***]. |
|
3. |
Provision of Documents. For the performance of the Services, PRIME shall provide [***] with documents, information, data and so forth (including duplicates and copies, hereinafter referred to as the “Service Documents”). If it materially delays or suspends performance of the Services, and such delay is not attributable only to Subcontractor and/or [***], then the parties including [***] shall discuss and negotiate in good faith on revised timeline and re-staffing or re-allocation of resources. |
|
4. |
Respect for Human Rights of Subject. The Parties shall give the priority to the respect of human rights of the subjects, and shall protect the privacy of the subjects in the course of the execution of clinical trial and process of the Monitoring-related Services, and ensure patient safety. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 26 of 44
|
5. |
Confirmation and Instruction. PRIME has the right to give [***] instructions regarding performance of the Services. The instructions shall be made in writing, as a general rule. In the event any instruction is given in a form other than writing out of necessity, a document specifying such instruction shall be delivered to [***] thereafter as soon as possible. |
|
6. |
Reporting. [***] shall provide a written report about actions taken based on the preceding sections without delay to PRIME. |
|
7. |
Compensation. For performance of these Services, PRIME shall pay to [***], upon [***]'s invoice, an amount equal to the Project Costs set forth in Appendix 3, which amount shall be payable pursuant to the Payment Schedule set forth in Appendix 4. [***]. |
|
8. |
Term and Termination. The term of this Task Order shall commence upon execution of this Task Order by Subcontractor and PRIME shall continue until completion of Services as described in Appendix 1, provided, however, either Party may terminate this Task Order in accordance with the Master Subcontract Agreement. |
|
9. |
Archival Documents of the Services. Subcontractor shall make [***] store the following materials (the “Records”) which may certify the reliability and quality of the Monitoring-related Services, [***], for [***] after the termination of the Services, in accordance with the SOP. The manner of storing the Records and the treatment thereof after the expiration of the storing term and the expenses shall be determined through a separate and mutual consultation between the Parties including [***]. |
|
(1) |
Essential Documents which are defined in GCP |
|
(2) |
Any other materials which Subcontractor is obligated to store by the SOP. |
|
10. |
Survival. Notwithstanding the terms of Master Subcontract Agreement, upon termination or expiration of this Task Order, the obligations of the Parties will cease other than the obligations under the following provisions, which will remain in full force and effect to the extent provided below: |
Article 8 (CONFIDENTIALITY) of the Master Subcontract Agreement will survive for [***] after the termination of this Task Order.
|
11. |
Sponsor. The Parties hereto acknowledge and agree that the Sponsor is a third-party beneficiary under this Task Order, entitled to enforce directly and all of its rights and PRIME'S rights hereunder. |
|
12. |
MSA. The provisions of the Master Subcontract Agreement are hereby expressly incorporated by reference into and made a part of this Task Order. |
|
13. |
Project Schedule. The Project Schedule for this Task Order is attached as Appendix 2. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 27 of 44
|
14. |
Limitation of Liability. IN ADDITON TO THE TERMS OF ARTICLE 15 OF MASTER SUBCONTRACT AGREEMENT, THE PARTIES AGREE TO THE TOTAL LIABILITY OF SUBCONTRACTOR UNDER OR IN CONNECTION WITH THIS TASK ORDER SHALL BE LIMITED TO THE SUM OF THE PAYMENTS FOR SUBCONTRACTOR AND THE SERVICES SET FORTH IN THIS TASK ORDER ON APPENDIX 3 RECEIVED BY [***] FROM PRIME UNDER THIS TASK ORDER EXCEPT IN CASE OF (1) WILLFUL MISCONDUCT, GROSS NEGLIGENCE OF SUBCONTRACTOR OR [***], OR (ii) AN ACTION OR INACTION THAT IS NOT IN COMPLIANCE WITH THIS TASK ORDER OR THE PROTOCOL, OR BREACH OF ANY APPLICABLE FEDERAL, STATE, OR LOCAL LAW TO THE EXTENT THAT CAUSE MATERIAL LOSS TO PRIME. |
|
15. |
Conflict. In the event of any conflict between the terms of the Master Subcontract Agreement or this Task Order, this Task Order shall govern. |
|
16. |
Governing Law. This Task Order shall be governed in accordance with the laws of Japan. |
|
17. |
Effectiveness. All other terms and conditions of the Master Subcontract Agreement and this Task Order remain in full force and effect. All capitalized terms not defined in this Task Order have the meanings given to them in the Master Subcontract Agreement. |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 28 of 44
IN WITNESS WHEREOF, the Parties have hereunto signed this Task Order effective as of the day and year first written above.
MEDPACE, INC.
|
Signature: |
/s/ Xxxx Xxxxx |
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By: |
Xxxx Xxxxx |
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Title: |
Vice President Commercial Operations |
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[***]
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Signature: [***] |
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By: [***] |
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Title: Chairman and CEO |
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|
List of Appendices:
Appendix 1: Scope of Work
Appendix 2: Project Schedule
Appendix 3: Project Budget
Appendix 4: Payment Schedule
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 29 of 44
Appendix 1: Scope of Work
|
Item |
Description |
|
[***] |
[***] |
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[***] |
[***] |
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[***] |
[***] |
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[***] |
[***] |
[***] |
ITEM |
DESCRIPTION |
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[***] |
[***] |
[***] |
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[***] |
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[***] |
[***] |
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[***] |
[***] |
[***] |
Appendix 2: Project Schedule
|
MILESTONE |
APPROXIMATE DATE |
|
[***] |
[***] |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 30 of 44
Appendix 3: Project Budget
|
|
Estimation Date: [***] |
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1. [***] |
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Detailed cost estimate |
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CHS-0214-05 study [***] |
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Total: |
[***] |
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Summary |
Unit price [***] |
[***] |
Cost [***] |
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I. [***] |
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1. [***] |
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(1) [***] |
[***] |
[***] |
[***] |
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(2) [***] |
[***] |
[***] |
[***] |
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(3) [***] |
[***] |
[***] |
[***] |
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(4) [***] |
[***] |
[***] |
[***] |
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2 [***] |
|||
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(1) [***] |
[***] |
[***] |
[***] |
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(2) [***] |
[***] |
[***] |
[***] |
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(3) [***] |
[***] |
[***] |
[***] |
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(4) [***] |
[***] |
[***] |
[***] |
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3 [***] |
[***] |
[***] |
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II. [***] |
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1. [***] |
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2. [***] |
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[***] |
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3. [***] |
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4. [***] |
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[***] |
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III. [***] |
[***] |
[***] |
[***] |
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Total [***] |
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Note: |
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- [***] |
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- [***] |
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- [***] |
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 31 of 44
Appendix 4: Payment Schedule
Subcontractor will submit, in accordance with the Project Budget, itemized invoice on [***]. Such invoice will be [***]. Such invoice itemization shall [***] to allow for [***].
Pass-Through expenses will be paid by [***] on [***].
In no event shall total costs for Services rendered by Subcontractor under this Task Order exceed the amount of [***] without [***].
PRIME shall make payments to Subcontractor by wire transfer to its designated bank account within [***] after [***] as applicable.
Subcontractor shall send all invoices to the following PRIME accounting contact to the email address by PDF:
The invoice should indicate the following information.
Medpace, Inc.
0000 Xxxxxxx Xxx
Xxxxxxxxxx, Xxxx 00000
Tel: x0.000.000.0000
Fax: x0.000.000.0000
E-mail: [***]
Invoices must be received within [***] of the [***] included in the invoice. Invoices received [***] will [***].
Within [***] of completion of the Services, Subcontractor shall submit a final invoice to PRIME according to the terms in this Agreement and the particular Task Order.
Other as set for the in this Task Order, payment terms shall be as defined in Section 4 of the Master Subcontract Agreement.
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 32 of 44
CONFIDENTIAL
|
Medpace, Inc. |
Estimation Date: [***] |
|
|
Estimate #[***] |
|
Cost Estimate |
|
|
CHS-0214-05 study [***] |
[***] |
|
[***] |
|
|
ITEMS |
Current [***] |
Current [***] |
Previous [***] |
Previous [***] |
Balance [***] |
Balance [***] |
|
[***] |
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1. [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
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2. [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
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Total |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
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||||||
|
[***] |
Current [***] |
Current [***] |
Previous [***] |
Previous [***] |
Balance [***] |
Balance [***] |
|
1) [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
2) [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
3) [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
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Total |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
Grand Total |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
Note
- [***]: [***]
- [***]: [***]
- [***]
- [***]
- [***]
- [***]
- [***]
- [***]
[***]
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 33 of 44
CONFIDENTIAL
Estimation Date: [***]
Estimate #[***]
1. [***]
Detailed cost estimate
CHS-0214-05 study [***]
[***]
|
Total: |
[***] |
|
Summary [***] [***] [***] [***] |
[***] |
[***] |
Balance |
|
I Site payment management |
[***] |
[***] |
[***] |
|
[***] [***] presumably [***] [***] [***] sites |
[***] |
[***] |
[***] |
|
[***] |
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* [***] |
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* [***] |
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II [***] |
[***] |
[***] |
[***] |
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[***] |
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[***] |
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●[***] |
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●[***] |
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[***] |
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●[***] |
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[***] |
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●[***] |
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[***] |
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●[***] |
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●[***] |
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III [***] |
[***] |
[***] |
[***] |
|
III [***] |
[***] |
[***] |
[***] |
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Total [***] |
[***] |
[***] |
[***] |
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|||
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V [***] |
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1 [***] |
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2 [***] |
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3 [***] |
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4 [***] |
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5 [***] |
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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 34 of 44
CONFIDENTIAL
Estimation Date: [***]
Estimate #[***]
2. [***]
Detailed cost estimate
|
―Assumptions― |
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||
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1) [***]: |
[***] |
12) [***]: [***] |
||||
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2) [***]: |
[***] |
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||
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3) [***]: |
[***] |
①[***]: |
[***] |
|||
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4) [***]: |
[***] |
②[***]: |
[***] |
|||
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5) [***]: |
[***] |
③[***]: |
[***] |
|||
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6) [***]: |
[***] |
④[***]: |
[***] |
|||
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7) [***]: |
[***] |
⑤[***]: |
[***] |
|||
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8) [***] |
[***] |
⑥[***] |
[***] |
|||
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9) [***] |
[***] |
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||
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10)[***]: |
[***] |
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||
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[***]: |
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[***] |
||
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Total: |
[***] |
|
Summary |
Unit price [***] |
[***] |
[***] |
[***] |
[***] |
Balance |
|
I [***] |
|
|
|
[***] |
[***] |
[***] |
|
1 [***] |
[***] |
|
[***] |
[***] |
[***] |
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2 [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
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II [***] |
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[***] |
[***] |
[***] |
|
1 [***] |
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|
[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
||
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2 [***] |
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[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
||
|
[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
||
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3 [***] |
|
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[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
||
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 [***] |
|
|
|
|
|
|
|
[***] |
|
|
|
|
|
|
|
1) [***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
1) [***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
||
|
[***] |
|
|
|
|
|
|
|
1) [***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
1) [***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
|
[***] |
|
|
|
|
|
|
|
1) [***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
1) [***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
||
|
|
|
|
|
|
|
|
|
i) [***] |
|
|
|
|
|
|
|
[***] |
|
|
|
|
|
|
|
ii) [***] |
|
|
|
|
|
|
|
[***] |
|
|
|
|
|
|
|
iii) [***] |
|
|
|
|
|
|
|
iv) [***] |
|
|
|
|
|
|
|
v) [***] |
|
|
|
|
|
|
|
vi) [***] |
|
|
|
|
|
|
|
vii) [***] |
|
|
|
|
|
|
|
vii) [***] |
|
|
|
|
|
|
|
ix) [***] |
|
|
|
|
|
|
|
x) [***] |
|
|
|
|
|
|
|
xi) [***] |
|
|
|
|
|
|
|
xii) [***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 [***] |
|
|
|
|
|
|
|
[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
III [***] |
|
|
|
[***] |
[***] |
[***] |
|
1 [***] |
|
|
|
|
[***] |
[***] |
|
[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
||
|
[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
||
|
[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
||
|
[***] |
|
|
|
|
|
|
|
2 [***] |
|
|
|
|
|
|
|
[***] [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
|
|
|
|
|
|
|
3 [***] |
|
|
|
|
|
|
|
[***] [***] [***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
|
IV [***] |
|
|
|
[***] |
[***] |
[***] |
|
V [***] |
|
|
|
[***] |
[***] |
[***] |
|
Total [***] |
|
|
|
[***] |
[***] |
[***] |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 35 of 44
|
Timeline |
CONFIDENTIAL |
|
[***] |
|
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 36 of 44
|
Actual expenses |
CONFIDENTIAL |
Estimation Date: [***]
Estimate [***]
Actual expenses
Actual expenses:
(1) [***]
1) [***]
2) [***]
3) [***]
(2) [***]
1) [***]
2) [***]
(3) [***]
1) [***]
2) [***]
(4) [***]
[***]
[***]
(5) Others
1) [***]
2) [***]
3) [***]
(6) [***]
[***]
(7) [***]
[***]
(8) [***]
[***]
(9) [***]
[***]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 37 of 44
APPENDIX H: Investigator Payment Estimate Detail
See attached budget on next page.
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 38 of 44
|
Sponsor |
Coherus |
|
|
|
|
|
|
|
|
|
Protocol |
[***] |
|
|
|
|
|
|
|
|
|
Date |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grand Total |
[***] |
|
|
|
|
|
Patient Costs |
[***] |
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
Country |
[***] |
[***] |
[***] |
Total |
|
Country |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
Total |
|
|
[***] |
[***] |
|
TOTAL |
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
Patient Costs |
[***] |
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
Country |
[***] |
[***] |
[***] |
Total |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
Total |
|
|
[***] |
[***] |
|
|
|
|
|
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 39 of 44
|
Site Costs [***] |
|
|
|
|
[***] |
[***] |
|
|
|
Country |
[***] |
[***] |
Total |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
|
Total |
|
[***] |
[***] |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 40 of 44
|
Coherus |
|
|
|
|
|
|
|
|
|
|
Protocol |
[***] |
|
|
|
|
|
|
|
|
|
Date |
[***] |
|
|
||||||
|
|
|
[***] |
[***] |
|
|||||
|
Visit |
Cost |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
Day |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
[***] |
|
[***] |
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
Total [***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Study |
|
[***] |
|
|
|
|
|
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 41 of 44
|
Coherus |
|
|
|
|
|
|
|
|
|
|
Protocol |
[***] |
|
|
|
|
|
|
|
|
|
Date |
[***] |
|
|
||||||
|
|
|
[***] |
[***] |
|
|||||
|
Visit |
Cost |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
Day |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
|
|
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
|
|
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
|
|
|
|
[***] |
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***]] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
Total [***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Study |
|
[***] |
|
|
|
|
|
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 42 of 44
|
|
|
[***] |
[***] |
|
|
|
|
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Country |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
Total |
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
[***] |
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Country |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
Total |
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
|
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 43 of 44
APPENDIX I: [***]
The table below reflects [***] included in this Task Order. Any [***] may require [***].
|
JobTitle |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
JobTitle |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
|
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] |
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Medpace Task Order #23
COHERUS BIOSCIENCES, INC
ETA305
Page 44 of 44
